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Blood Glucose Meters

According to the International Diabetes Federation, in 2015, 415 million people worldwide (over 9% of the global population) are living with diabetes in 2015, and another 318 million people were at high risk of developing type 2 diabetes.

It has been estimated that one person dies from diabetes every six seconds and that 5 million deaths were caused by diabetes in 2015. Worryingly, the epidemic shows no signs of relenting, with the number of people living with diabetes expected to reach 642 million by 2040.

Accuracy of Blood Glucose Meters

Development of blood glucose meter validation

As listed below, protocols to validate blood glucose meters independently were initiated by the American Diabetes Association in 1987. Several organisations, including the FDA, the Canadian Standards Association, and the US based Clinical and Laboratory Standards Institute (or the National Committee for Clinical Laboratory Standards as it was known prior to 2005) also developed validation criteria, many of which were revised. Apart from the 2013 CLSI standard, most of these have since been either withdrawn or superseded. The ISO, in conjunction with CEN, developed a draft standard 15197 in 2000, which was finalised in 2002 and revised in 2003 and 2013. The most recent call for new validation procedures has been made by Klonoff et al in 2015. [2]

Error Grids

Error grid analysis, to quantify the potential harm of error levels in blood glucose meters for self-measurement, as against reference measurements, was first postulated by Clarke et al in 1987 with the grid, described in the paper, becoming known as the Clarke Error Grid. [3] Parkes et al. published an alternative Consensus Error Grid, also known as the Parkes Error Grid, in 2000 [4] and this now forms part of ISO 15197:2013. Klonoff et al described a Surveillance Error Grid in 2014 [5].